EP3127500B1 - Internal bone fixation device - Google Patents

Internal bone fixation device Download PDF

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Publication number
EP3127500B1
EP3127500B1 EP16182892.6A EP16182892A EP3127500B1 EP 3127500 B1 EP3127500 B1 EP 3127500B1 EP 16182892 A EP16182892 A EP 16182892A EP 3127500 B1 EP3127500 B1 EP 3127500B1
Authority
EP
European Patent Office
Prior art keywords
bone
fixation device
bone fixation
head portion
weakened
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP16182892.6A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3127500A1 (en
Inventor
Lien-Guo DAI
Ya-Hui Chang
Shiuan-Yuan Dai
Shiuan-Te Dai
Shiuan-Jen Dai
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
HUMAN ORIGIN BIOTECHNOLOGY CO Ltd
Original Assignee
HUMAN ORIGIN BIOTECHNOLOGY CO Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by HUMAN ORIGIN BIOTECHNOLOGY CO Ltd filed Critical HUMAN ORIGIN BIOTECHNOLOGY CO Ltd
Publication of EP3127500A1 publication Critical patent/EP3127500A1/en
Application granted granted Critical
Publication of EP3127500B1 publication Critical patent/EP3127500B1/en
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/842—Flexible wires, bands or straps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive

Definitions

  • the embodiments disclosed herein relate to medical devices for use in repairing a weakened or fractured bone, and more particularly to internal bone fixation devices and methods for using the devices to repair a weakened or fractured bone.
  • Fracture repair is the process of rejoining and realigning the ends of broken bones. Fracture repair is required when there is a need for restoration of the normal position and function of the broken bone. Throughout the stages of fracture healing, the bones must be held firmly in the correct position and supported until it is strong enough to bear weight. In the event the fracture is not properly repaired, malalignment of the bone may occur, resulting in possible physical dysfunction of the bone or joint of that region of the body
  • bone fixation devices such as wires, plates, rods, pins, nails, and screws to support the bone directly, and/or the addition of bone cement mixtures to a fractured bone.
  • subsequent surgeries are required to remove these bone fixation devices after the fractured bones are healed.
  • Document DE 10 2015 122 709 A1 describes a conventional band for securing the bone.
  • Document WO 2014 014 815 A1 describes a conventional bone fixation device for compressing a bone using a tension strip to surround the surface of the bone.
  • Document EP 0 201 905 A2 discloses a self retaining permanently tensionable synthetic tie for use in surgery and orthopaedics.
  • Document US 2005 288 674 A1 describes a bio-absorbable bone tie with a convex head which is an elongated band having a convex head portion and is used for securing fragments of a fractured bone together.
  • Document JP 2000 201 941 A discloses a securing element for surgical use.
  • the securing element has an elongated tie and a locking device adapted to engage with the tie to secure the tie and the locking device in a predetermined position.
  • Document DE 19 527 151 A1 describes a device for bone fragment fixation.
  • the device has a tension element, in the form of a flat band, which is formed into a loop or cylindrical shape.
  • the improved bone fixation device is easy to use, biodegradable, and causes minimal damage to the bone and supporting tissues.
  • a device for repairing a fractured bone as defined by claim 1. It includes a head portion having a conduit and a plurality of pawls formed therein along one side of the conduit; and an elongation strip having a hooked end and a plurality of ratchet teeth formed thereon along one side of the body of the strip.
  • the head portion is connected to the non-hooked end of the elongation strip at an obtuse angle between 100-170 degrees, and the plurality of pawls of the head portion may engage the plurality of ratchet teeth when the elongation strip is inserted into the conduit of the head portion to form a loop around the weaken or facture bone.
  • the head portion and the elongation strip of the bone fixation device are connected by forming a joined portion having an arc of 0.175 rad to 1.4 rad.
  • the bone fixation device is composed by a bioabsorable material.
  • bioabsorable material include, but are not limited to, alginate, biphasic calcum phosphate, calcium phosphate, calcium sulfate, chitosan, collagen, gelatin, hydroxyapatite (HA), polyalkylene esters, polyanhydrides, polyamide esters, polydioxanone, polyethylene glycol (PEG), polyactic acid (PLA) poly(lactic-co-glycolic acid) (PLGA), PLA-PLGA copolymer, poly(3-hydroxybutyrate-co-3-hydroxyvalerate), polyvinyl esters, polyvinyl alcohols, and tricalcium phosphate.
  • the bone fixation device is an integral article.
  • the present bone fixation device may be used for the repair of bones that are weakened or fractured due to any of the bone diseases, which include, but are not limited to, osteoporosis, achondroplasia, bone cancer, fibrodysplasia ossificans progressiva, fibrous dysplasia, legg calve perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis, osteopenia, osteoporosis, Paget's disease, scoliosis, and other similar diseases; or for the repair of bones that are weakened or fractured due to an injury, for example, a fall.
  • the bone diseases include, but are not limited to, osteoporosis, achondroplasia, bone cancer, fibrodysplasia ossificans progressiva, fibrous dysplasia, legg calve perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis, osteopenia, osteoporosis, Paget's disease, scolio
  • weakened or fractured bone examples include, but are not limited to, metacarpal bone in the hand, the femur, tibia, fibula, humerus, ulna, radius, metatarsals, phalanx, phalanges, ribs, spine, vertebrae, clavicle and the like.
  • the bone fixation device may be used in a method for repairing a weaken or fractured bone that includes providing a device for use in repairing the weaken or fractured bone, the device comprises in its structure, a head portion having a conduit and a plurality of pawls formed therein along one side of the conduit; and an elongation strip having a hooked end and a plurality of ratchet teeth formed thereon along one side of the body of the strip.
  • the head portion is connected to the non-hooked end of the elongation strip at an obtuse angle between 100-170 degrees, and the plurality of pawls of the head portion may engage the plurality of teeth when the elongation strip is inserted into the conduit of the head portion to form a loop around the weaken or facture bone.
  • the head portion and the elongation strip of the bone fixation device are connected by forming a joined portion having an arc of 0.175 rad to 1.4 rad.
  • the bone fixation device is composed by a bioabsorable material.
  • bioabsorable material include, but are not limited to, alginate, biphasic calcum phosphate, calcium phosphate, calcium sulfate, chitosan, collagen, gelatin, hydroxyapatite (HA), polyalkylene esters, polyanhydrides, polyamide esters, polydioxanone, polyethylene glycol (PEG), polyactic acid (PLA) poly(lactic-co-glycolic acid) (PLGA), PLA-PLGA copolymer, poly(3-hydroxybutyrate-co-3-hydroxyvalerate), polyvinyl esters, polyvinyl alcohols, and tricalcium phosphate.
  • the device is an integral article.
  • the term "host,” “subject,” or “patient” is used interchangeably herein and refers to a mammal, in which the present internal bone fixation device may be applied therein to stabilize any weaken or fractured bone.
  • the term “mammal” refers to all members of the class Mammalia, including humans, primates, domestic and farm animals, such as rabbit, pig, sheep, and cattle; as well as zoo, sports or pet animals; and rodents, such as mouse and rat.
  • the term “host,” “subject,” or “patient” intended to refer to both the male and female gender unless one gender is specifically indicated. Accordingly, the term “host,” “subject,” or “patient” comprises any mammal which may benefit from the bone fixation device of the present disclosure.
  • Examples of a “host,” “subject,” or “patient” include, but are not limited to, a human, rat, mouse, guinea pig, monkey, pig, goat, cow, horse, dog, cat, bird and fowl.
  • the patient is a human.
  • the devices disclosed herein act as internal bone fixation devices for stabilize internal weaken or fractured bones without the need of trocars or guide wires that commonly required when conventional bone fixation devices are employed. Further, the present internal bone fixation devices are biodegradable, thus eliminating the need of a subsequent surgery to remove the device from its host after the fractured bones are healed.
  • the bone fixation device 100 includes a head portion 150, and an elongation strip 110 connected to the head portion 150 at an obtuse angle (A).
  • the head portion 150 comprises in its structure, a conduit 152, and a plurality of pawls 154 formed therein along one side of the conduit 152.
  • the elongation strip 110 has an elongation body having a hooked end 110L, a non-hooked end 110U connected to the head portion 150, and a plurality of ratchet teeth 122 formed thereon along one side of the elongation body of the strip 110.
  • the tip of the hooked end 110L is sharpen enough to cut through muscles around a fractured bone, thus when the device 100 is in use, the elongation strip 110 can be inserted from the cut muscles and go around the fractured bone, then into the conduit 152 of the head portion 150 to form a loop around the fractured bone, the loop is then tighten by pulling the elongation strip 110 through the conduit 152 to engage the plurality of ratchet teeth 122 with the plurality of pawls 154, thereby stabilizing the fractured bone ( FIGs 2A and 2B ). Engagement of the ratchet teeth 122 and the pawls 154 also prevents reverse movement of the strip 110 through the conduit 152 of the head portion 150. That way, the bone fixation device 100 is tighten around the weakened or fractured bone to hold the weakened or fractured bone in place.
  • the elongation strip 110 and the head portion 150 are connected at an obtuse angle ( A ) between 100-170 degrees, such as 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, and 170 degrees; more preferably between 110-160 degrees, such as 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, and 160 degrees.
  • the obtuse angle between the elongation strip 110 and the head portion 150 allows the present bone fixation device 100 to comply with the shape or conformation of a bone surface when stabilizing a fractured bone, so that when the loop is tighten, such as by pulling the elongation strip 110 through the conduit 152 to engage the plurality of ratchet teeth 122 with the plurality of pawls 154, the stress generated therein can be distributed evenly to prevent the elongation strip 110 from being broken.
  • FIG 3 depicts another embodiment of the present bone fixation device 300, in which the structure of the device 300 is relatively the same with the device 100 described above in FIGs 1 and 2 , except the connected portion between the elongation strip 310 and the head portion 350.
  • the elongation strip 310 and the head portion 350 are connected by forming a joined portion ( J ) having an arc of 0.175 to 1.4 rad (radian) at an obtuse angle ( A ) as defined above.
  • the term "radian” refers to a unit for measuring angles.
  • the present bone fixation device 100, 300 is preferably made by a material that is compatible and absorbable by its host (e.g. , a human), such that the present device may be left inside the host after a fractured bone is stabilized, thereby eliminates the need of a subsequent surgery to remove the device therefrom.
  • its host e.g. , a human
  • Examples of such material include, but are not limited to, alginate, biphasic calcum phosphate, calcium phosphate, calcium sulfate, chitosan, collagen, gelatin, hydroxyapatite (HA), polyalkylene esters, polyanhydrides, polyamide esters, polydioxanone, polyethylene glycol (PEG), polyactic acid (PLA) poly(lactic-co-glycolic acid) (PLGA), PLA-PLGA copolymer, poly(3-hydroxybutyrate-co-3-hydroxyvalerate), polyvinyl esters, polyvinyl alcohols, and tricalcium phosphate.
  • alginate biphasic calcum phosphate, calcium phosphate, calcium sulfate, chitosan, collagen, gelatin, hydroxyapatite (HA), polyalkylene esters, polyanhydrides, polyamide esters, polydioxanone, polyethylene glycol (PEG), polyactic acid (PLA) poly
  • the preset bone fixation device is formed into an integral article.
  • the present bone fixation device 100, 300 may come in various sizes and dimensions, and a physician may chose a suitable size of the present device according to the size and location of the weakened or fractured bone needs to be stabilized.
  • the head portion 150, 350 of has a length of about 0.3-6.5 cm, such as 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0,
  • the elongation strip 110, 310 has a thickness of about 0.2-1 cm, such as 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, and 1 cm, preferably about 0.2-0.5 cm, such as 0.2, 0.3, 0.4, and 0.5 cm; and a width of about 0.2-5 cm, such as 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 and 5 cm, preferably about 0.5-3 cm, such as 0.5, 0.6, 0.7, 0.8, 0.9
  • the non-hooked end 110L, 310L of the elongation strip 110, 310 has a shape of a circle of 2/10 - 9/10, such as a circle of 2/10, 3/10, 4/10, 5/10, 6/10, 7/10, 8/10 and 9/10; further, the tip of non-hooked end 110L, 310L is spaced apart from the elongation body by a distance (D) of about 0.5-7 cm, such as 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0
  • the bone fixation device disclosed herein may be used for the repair of bones that are weakened or fractured due to any of the bone diseases, which include, but are not limited to, osteoporosis, achondroplasia, bone cancer, fibrodysplasia ossificans progressiva, fibrous dysplasia, legg calve perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis, osteopenia, osteoporosis, Paget's disease, scoliosis, and other similar diseases.
  • the bone fixation device disclosed herein may also be used for the repair of bones that are weakened or fractured due to an injury, for example, a fall.
  • weakened or fractured bone examples include, but are not limited to, metacarpal bone in the hand, the femur, tibia, fibula, humerus, ulna, radius, metatarsals, phalanx, phalanges, ribs, spine, vertebrae, clavicle and other bones, which are still within the scope and spirit of the disclosed embodiments.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)
EP16182892.6A 2015-08-05 2016-08-04 Internal bone fixation device Not-in-force EP3127500B1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
TW104125361A TWI572317B (zh) 2015-08-05 2015-08-05 體內固定裝置

Publications (2)

Publication Number Publication Date
EP3127500A1 EP3127500A1 (en) 2017-02-08
EP3127500B1 true EP3127500B1 (en) 2019-06-12

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EP16182892.6A Not-in-force EP3127500B1 (en) 2015-08-05 2016-08-04 Internal bone fixation device

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US (1) US20170035480A1 (zh)
EP (1) EP3127500B1 (zh)
TW (1) TWI572317B (zh)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3717515A2 (en) 2017-12-01 2020-10-07 Seattle Genetics, Inc. Cd47 (masked) antibodies and uses thereof for treating cancer
BR112023003653A2 (pt) 2020-09-01 2023-03-28 Dsm Ip Assets Bv Folha compósita de poliuretano, método de fabricação dessa folha compósita e uso da mesma na fabricação de um implante médico
CN112353477A (zh) * 2020-10-29 2021-02-12 北京市春立正达医疗器械股份有限公司 一种捆绑带固定用的收紧器
WO2023110744A1 (en) 2021-12-13 2023-06-22 Dsm Ip Assets B.V. Composite sheets and medical implants comprising such sheets

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DE3517204A1 (de) * 1985-05-13 1986-11-13 Gerald Dr. 8000 München Hauer Dauerspannbares kunststoffband mit selbsthalterung
DE19527151A1 (de) * 1995-07-25 1997-01-30 Gundolf Ferdinand Vorrichtung zur Osteosynthese von Knochenfragmenten, insbesondere zur Fixation von Knochenfrakturen
JP2000201941A (ja) * 1999-01-13 2000-07-25 Kyowa Tokei Kogyo Kk 骨結束バンド
US6835197B2 (en) * 2001-10-17 2004-12-28 Christoph Andreas Roth Bone fixation system
US7008429B2 (en) * 2004-06-23 2006-03-07 Golobek Donald D Bio-absorbable bone tie with convex head
US8292944B2 (en) * 2004-12-17 2012-10-23 Reva Medical, Inc. Slide-and-lock stent
US9078644B2 (en) * 2006-09-29 2015-07-14 Biomet Sports Medicine, Llc Fracture fixation device
CN201782810U (zh) * 2010-08-11 2011-04-06 长乔企业有限公司 调整型脊椎棘突撑开器
CA2868471C (en) * 2012-03-28 2020-09-01 DePuy Synthes Products, LLC Bone fixation member systems and methods of use
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TWI523634B (zh) * 2013-12-02 2016-03-01 財團法人金屬工業研究發展中心 骨髓內固定裝置
DE102015122709A1 (de) * 2014-12-23 2016-06-23 MEDICARE-PRODUKTE Michael Baade e.K. Cerclageband

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Also Published As

Publication number Publication date
EP3127500A1 (en) 2017-02-08
US20170035480A1 (en) 2017-02-09
TW201705917A (zh) 2017-02-16
TWI572317B (zh) 2017-03-01

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